出凝血检验国际标准品互通性研究与国家标准品研制

The accuracy of coagulation test is very important for the diagnosis and therapy of the thrombotic and hemorrhagic diseases. The comparability and accuracy of test results are mainly achieved by calibrating the measurement system using reference materials which are traceable to the international standards. However, the calibration effect is directly related to the commutability of the international standards. Our previous study showed that some international standards presented a significant matrix effect, which resulted in significant difference between some test systems. The results from these systems could not meet the clinical requirements. Therefore, in consideration of poor comparability and accuracy of coagulation test relating to the commutability of international standards, we intend to explore the suitable methods and criteria for commutability evaluation based on biological variation and Deming regression, and evaluate the commutability of several international standards across the routine test systems. Then we will prepare the national standards traceable to international standards, and use the national standards to test the feasibility of carrying out standardization and harmonization of coagulation test. This study will confirm the commutability of international standards of the important commonly used coagulation tests for the first time. And it is the first time to use traceable national standards to carry out standardization and harmonization, which is an effective practice to improve comparability and accuracy of coagulation test.

出凝血检验结果的准确性对于相关疾病的诊疗具有重要意义。使用能溯源至国际标准品的标准物质对检测系统进行校准是保证检测结果准确可比的重要手段，但校准效果与国际标准品的互通性直接相关。项目组前期研究发现部分检测项目国际标准品的互通性欠佳，导致检测系统间结果差异不能满足临床需求。为此，针对不同医院出凝血检验项目结果差异大可能与国际标准品的互通性有关的问题，本课题拟研究基于生物学变异和Deming回归分析的评价标准，探索国际标准品的互通性评价方法，并对多种国际标准品在常用检测系统间的互通性进行评价。同时，研制溯源至国际标准品且具有互通性的国家标准品，探讨使用国家标准品解决标准化和一致化问题的可行性。本研究将首次确认出凝血检验项目国际标准品的互通性，在国内研制并应用具有溯源性和互通性的国家标准品首次实施标准化和一致化，有效解决检验结果准确性和可比性问题。

出凝血检验结果的准确性对于疾病诊疗具有重要意义，使用溯源至国际标准品的标准物质对检测系统进行校准是保证检测结果准确可比的重要手段，但校准效果与国际标准品的互通性直接相关。项目组研究并确定了临床重要常用出凝血检验项目（纤维蛋白原、蛋白C、抗凝血酶、蛋白S、凝血因子VIII、凝血因子IX）标准品互通性评价的适宜方法和结合临床需求的判定标准；评价了WHO国际标准品和候选国家标准品在主流品牌代表性检测系统间的互通性；研制候选国家标准品，在均匀性和稳定性评价结果符合要求的基础上，依据互通性评价结果制定候选标准品的溯源和定值方案，并予以实施；探讨使用候选国家标准品改进结果可比性和准确性的有效性。本项目历时四年，共发表标注有基金号的论文7篇，其中SCI论文4篇，中华系列杂志发表论文3篇，尚有2篇SCI论文待发表。通过本项目的实施，培养硕士研究生8名，5名已毕业，3名在读。候选国家标准品的研制与应用有助于提高实验室检测能力，有效推动出凝血常用重要检验项目的标准化和质量改进。